Clearside Biomedical said the primary endpoint was not achieved in its 460-patient, phase 3 SAPPHIRE investigating the superiority of Xipere (formerly suprachoroidal CLS-TA) in combination with Eylea, compared to intravitreal Eylea monotherapy, for combating RVO in treatment-naïve patients. The primary endpoint was the proportion of patients in the combination treatment arm, compared to the Eylea-alone control arm, with improvements in BCVA from baseline of at least 15 letters ETDRS scale at 8 weeks after initial treatment.
“In the SAPPHIRE trial, approximately 50% of patients in both arms showed at least a 15 letter improvement in vision; unfortunately, there was no additional benefit for patients receiving Xipere together with intravitreal Eylea,” said Daniel White, CEO and President of Clearside, in a company news release. “In light of these 8-week topline data, we plan to discontinue clinical development of combination therapy for RVO, which includes SAPPHIRE and its companion phase 3 clinical trial, TOPAZ.”
“We believe the opportunity in our primary indication, uveitis, remains very attractive. Awareness and acceptance of the strong clinical profile of Xipere as a potential monotherapy in treating uveitic macular edema is growing, and we remain on track to submit our NDA for this indication before the end of this year,” added Mr. White.